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Journey through GI > Week 6 Powders 1 > Flashcards

Week 6 Powders 1 Flashcards

1
Q

What 2 things do we need to know to make a dosage form

A

physical and chemical properties

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2
Q

What is an api

A

active pharmaceutical ingredient

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3
Q

what is an excipient

A

inert ingredient which gives functionality to the dosage form

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4
Q

What 5 assumptions do we make about an API

Penny Bought Detective Analysis at an Acceptable Rate

A

API pure

API produced in bulk for pre formulation

Detect and identify any impurities and degradation products

Qualitative and Quantitative analysis

BP specification will include acceptable limits on any impurities

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5
Q

What is the purpose of pre formulation

A

Looking to understand the nature of the API

How it behaves alone
How it interacts with excipients

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6
Q

What chemical properties should be taken into the account of the API

A

Chemical Stability

Solubility

Crystal form

Hygroscopicity

Particle size

Flow

Segregation

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7
Q

What does knowledge of the chemical stability provide

A

Gives us information on

Temperature which affects sterilisation
pH
Moisture
Oxygen how to manufacture
Light which affects storage / packaging
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8
Q

What does accelerated stability include

A

use of high temperatures and humidity

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9
Q

What must an api be

A

they must have some aqueous solubility for therapeutic effect

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10
Q

what does a poor solubility lead to

A

erratic or incomplete absorption

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11
Q

what should solubility be checked at

A

over a range of temperatures and pH

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12
Q

How can we atler the solubility of an API

A

Salt Forms

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13
Q

What are the two categories of solid

A

Crystaline

Amorphous

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14
Q

What is an amorphous api

A

an api with no regular molecular lattice arrangement

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15
Q

what is a polymorph

A

a different crystal packing arrangement in a crystal

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16
Q

what is the consequence of a polymorph

A

a polymorph has different physicochemical and mechanical properties

solubility
stabilities
dissolution rates
melting points etc

17
Q

Why is it vital that the polymorphic form of the APi is known and consistent

A

due to physicochemical and mechanical properties being vital in formulation

it could mean that there would be unexpected behaviour and potentially big harm to the patient

18
Q

what is hygroscopicity

A

degree of moisture uptake by an API

19
Q

what can poor hygroscopicity cause

A

swelling / particle size increase
instability
degradation
microbial spoilage

20
Q

What are the 4 factors that affect processing

A

particle size and shape
bulk density
powder flow
compressibility

21
Q

why do smaller particles have faster dissolution rate for the same volume or mass

A

they have a larger surface area meaning that particle size affects the dissolution rate

22
Q

what is dissolution rate

A

The dissolution rate is defined as the rate or speed at which a drug substance dissolves in a medium.

23
Q

why is low bulk density bad

A

a low bulk density means a large volume so a large tablet thus inconvenient

24
Q

why is a range of bulk density bad

A

different tablet weights

25
Q

what is flow a key attribute of

A

granules and powders

26
Q

why is flow important

A

achieving uniformity of dosage and weight

27
Q

what state should a powder flow at to be considered for easy industrial production.

A

liquids

28
Q

what can poor flow cause

A

capping / lamination of tablets

29
Q

how can we change flow

A

change particle size

reduce inter particle forces

add excipients

change manufacturing equipment

30
Q

To make tablets what do you need

A

API and excipient particles to bind together via compaction

31
Q

What is plastic materials

A

deform by changing shape (plastic flow)

on compression doesnt get any new surfaces forming

plastic materials bond develop with time so need to dwell in tablet die longer

32
Q

Elastic materials

A

recover shape elastically after compression removed

bonding weak tablet will break by capping or lamination

33
Q

brittle materials

A

Fragment on compression

exposes new surfaces
can lead to high friability

34
Q

what is friability

A

the tendency of a solid substance to break into smaller pieces under duress or contact, especially by rubbing.

The opposite of friable is indurate

35
Q

why is sticking important to measure

A

if powder is sticky will adhere to punc hand die and can lead to variable tablet weights

Journey through GI (30 decks)

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